COMPARISON BETWEEN EFFICACY OF NOREPINEPHRINE AND PHENYLEPHRINE BOLUSES for PREVENTION OF SPINAL ANAESTHESIA INDUCED HYPOTENSION IN OBSTETRICAL PATIENTS UNDERGOING EMERGENCY CESAREAN SECTION-A Double Blind Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorDow University of Health Sciences

About this trial

The goal of this clinical trial is to learn if norepinephrine is more effective than phenylephrine for prevention of spinal anesthesia induced hypotension. The main questions it aims to answer are:

Does norepinephrine lower the incidence of spinal anesthesia induced hypotension in emergency obstetrical patients? We will compare effectiveness of norepinephrine and phenylephrine for the prevention of spinal anesthesia induced hypotension.

Participants will:

Be administered prophylactic boluses of both drugs right after spinal anesthesia induction and maternal hemodynamic parameters and neonatal APGAR scores will be recorded

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American society of anesthesiologists II and III patients

Age 18-40years

Gestational age 32 weeks and above

Disqualifiers

Patients with hypertensive disorders of pregnancy having baseline systolic blood pressure greater than 160 mmHg and diastolic blood pressure greater than 99 mmHg.

Baseline mean arterial pressure less than 70 mmHg.

Antepartum hemorrhage/intraoperative blood loss greater than 1000ml

history indicative of cardiovascular or neurological disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Norepinephrine Bolus

    Drug

    Prophylactic norepinephrine bolus of 8 micrograms will be administered right after spinal anesthesia induction. Rescue bolus of norepinephrine 4 micrograms will be administered in case of hypotension.

  • Phenylephrine bolus

    Drug

    Prophylactic phenylephrine bolus of 100 micrograms will be administered right after spinal anesthesia induction. Rescue bolus of phenylephrine 50 micrograms will be administered in case of hypotension.

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: Group PActive comparator 1 intervention
Group B: Group NExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of spinal anesthesia induced Hypotension

Prophylactic norepinephrine and phenylephrine boluses will be administered to both groups right after spinal anesthesia induction.greater than 80% drop of the Systolic blood pressure will be defined as hypotension.

Time frame
From induction of spinal anesthesia till delivery of neonate

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.